Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory
Abstract Background The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical tr...
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| Format: | Article |
| Language: | English |
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BMC
2017-09-01
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| Series: | BMC Medical Research Methodology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12874-017-0420-7 |
| _version_ | 1828764974409842688 |
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| author | Kevin P. Weinfurt Adrian F. Hernandez Gloria D. Coronado Lynn L. DeBar Laura M. Dember Beverly B. Green Patrick J. Heagerty Susan S. Huang Kathryn T. James Jeffrey G. Jarvik Eric B. Larson Vincent Mor Richard Platt Gary E. Rosenthal Edward J. Septimus Gregory E. Simon Karen L. Staman Jeremy Sugarman Miguel Vazquez Douglas Zatzick Lesley H. Curtis |
| author_facet | Kevin P. Weinfurt Adrian F. Hernandez Gloria D. Coronado Lynn L. DeBar Laura M. Dember Beverly B. Green Patrick J. Heagerty Susan S. Huang Kathryn T. James Jeffrey G. Jarvik Eric B. Larson Vincent Mor Richard Platt Gary E. Rosenthal Edward J. Septimus Gregory E. Simon Karen L. Staman Jeremy Sugarman Miguel Vazquez Douglas Zatzick Lesley H. Curtis |
| author_sort | Kevin P. Weinfurt |
| collection | DOAJ |
| description | Abstract Background The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped. Methods To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design. Results In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs. Conclusion A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity. |
| first_indexed | 2024-12-11T06:41:28Z |
| format | Article |
| id | doaj.art-46f4051a83654c05bd4058a62662f0c9 |
| institution | Directory Open Access Journal |
| issn | 1471-2288 |
| language | English |
| last_indexed | 2024-12-11T06:41:28Z |
| publishDate | 2017-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Research Methodology |
| spelling | doaj.art-46f4051a83654c05bd4058a62662f0c92022-12-22T01:17:13ZengBMCBMC Medical Research Methodology1471-22882017-09-0117111010.1186/s12874-017-0420-7Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH CollaboratoryKevin P. Weinfurt0Adrian F. Hernandez1Gloria D. Coronado2Lynn L. DeBar3Laura M. Dember4Beverly B. Green5Patrick J. Heagerty6Susan S. Huang7Kathryn T. James8Jeffrey G. Jarvik9Eric B. Larson10Vincent Mor11Richard Platt12Gary E. Rosenthal13Edward J. Septimus14Gregory E. Simon15Karen L. Staman16Jeremy Sugarman17Miguel Vazquez18Douglas Zatzick19Lesley H. Curtis20Department of Population Health Sciences, Duke University School of MedicineDuke Clinical Research InstituteKaiser Permanente Center for Health ResearchKaiser Permanente Center for Health ResearchPerelman School of MedicineBlockley HallKaiser Permanente Washington Health Research InstituteUniversity of WashingtonUniversity of California Irvine School of MedicineUniversity of WashingtonUniversity of WashingtonGroup Health Research InstituteDepartment of Community Health, Brown UniversityDepartment of Population Medicine, Harvard Pilgrim Health Care InstituteDepartment of Internal Medicine, Wake Forest School of Medicine, Medical Center BoulevardHospital Corporation of America Nashville TN, AND Texas A&M College of MedicineKaiser Permanente Washington Health Research InstituteCHB Wordsmith, Inc.Johns Hopkins Berman Institute of BioethicsUniversity of Texas Southwestern Medical CenterUniversity of Washington School of MedicineDuke Clinical Research InstituteAbstract Background The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped. Methods To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design. Results In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs. Conclusion A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.http://link.springer.com/article/10.1186/s12874-017-0420-7Embedded clinical trialsPragmatic researchPragmatic clinical researchCluster randomized trialsStakeholder engagement |
| spellingShingle | Kevin P. Weinfurt Adrian F. Hernandez Gloria D. Coronado Lynn L. DeBar Laura M. Dember Beverly B. Green Patrick J. Heagerty Susan S. Huang Kathryn T. James Jeffrey G. Jarvik Eric B. Larson Vincent Mor Richard Platt Gary E. Rosenthal Edward J. Septimus Gregory E. Simon Karen L. Staman Jeremy Sugarman Miguel Vazquez Douglas Zatzick Lesley H. Curtis Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory BMC Medical Research Methodology Embedded clinical trials Pragmatic research Pragmatic clinical research Cluster randomized trials Stakeholder engagement |
| title | Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory |
| title_full | Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory |
| title_fullStr | Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory |
| title_full_unstemmed | Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory |
| title_short | Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory |
| title_sort | pragmatic clinical trials embedded in healthcare systems generalizable lessons from the nih collaboratory |
| topic | Embedded clinical trials Pragmatic research Pragmatic clinical research Cluster randomized trials Stakeholder engagement |
| url | http://link.springer.com/article/10.1186/s12874-017-0420-7 |
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